News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Process characterization and validation is an important step in the product development journey and late-phase development, and it is required before transferring an existing manufacturing process.
PMSF is a small molecule serine protease inhibitor used to prevent unwanted proteolysis.
Would you like to enhance your downstream process, increase production capacity and reduce costs? This case study application note demonstrates how implementing inline volume reduction before a final diafiltration step can improve your process...
Download the eBook written by Catalent experts to learn about innovative products and techniques for scale-up of complex biologics, get optimal cell culture medium and feed to maximize performance potential, novel analytical techniques for monoclonal...
Accelerate Your Process Development. Your technology selection guide for the clarification of mAb processes.
The Cadence inline diafiltration (ILDF) device is designed for continuous processing, in-process buffer exchange or contaminant removal in various processes in a wide range of applications. This includes buffer exchange for final drug substance,...
In September 2017, BioPharma-Reporter.com conducted its second annual ‘state of the industry’ survey on its user base of biopharmaceutical industry professionals. The key objective of the survey was to gauge views about the current state of the global...
The Cadence™ BioSMB platform from Pall Life Sciences is the first disposable flow path, continuous multicolumn chromatography solution that is fully scalable from the process development (PD)...
For many years cylindrical stainless steel tanks have been used in biopharmaceutical production.The primary reason for the cylindrical shape was that it provided the mechanical stability required...
Single-use bioreactors have only been cylindrical in design, until now. The Allegro™ STR single-use, stirred tank bioreactor provides advantages over the traditional cylindrical shape. Download...
Virus filtration is a vital part of the viral clearance strategy in bioprocesses. In filtration, size exclusion mechanisms are orthogonal to other inactivation or removal techniques and target...
Learn the advantages of transferring from single column to continuous chromatography processes with connected unit operations. This poster titled “Demonstration of a mAb Chromatography Platform...
In May 2016, BioPharma-Reporter conducted its inaugural ‘state of the industry’ survey. The key objective of the poll was to gauge views about the current state of the biopharmaceutical...
Pharmaceutical fluid transfer involves many tubing-to-fitting connections, and unfortunately those connections can leak and result in contamination, production delays, lost income and headaches....
Pall’s single-pass tangential flow filtration (SPTFF) technology provides a simple solution for continuous concentration and optimization of DSP steps. The Cadence™ Inline Concentrator (ILC)...
The Applikon BioSep system is a unique, cell retention device for high-density perfusion processes. BioSep is the ultimate tool for cell culture perfusion from 100 ml scale bioreactor up to...
Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard pyrogen detection methods have drawbacks. The Limulus Amoebocyte Lysate (LAL) test only identifies...
Assessment of biosimilar molecules requires an orthogonal analytical approach. Any one particular analytical technique is not able to fully define the physical and biological characteristics of...